A comprehensive view of FDA Drug / Device Reviews. This page highlights a small sample of our full coverage.
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Eisai and Biogen disappointed by EMA's negative opinion on lecanemab for early Alzheimer's; the humanized anti-amyloid-beta monoclonal antibody was under review for mild cognitive impairment
Published:
July 26, 2024
by Biogen Inc.
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FDA Advisory Committee reviewed AstraZeneca’s Imfinzi for resectable lung cancer; AEGEAN Phase III trial shows 32% risk reduction in recurrence, progression, or death vs. chemotherapy alone
Published:
July 25, 2024
by AstraZeneca AB
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AskBio secures FDA Fast Track and UK MHRA Innovation Passport for AB-1005 gene therapy; AB-1005 targets moderate Parkinson’s disease with ongoing Phase II REGENERATE-PD trial expansion in the U.S. and EU
Published:
July 11, 2024
by Bayer AG
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FDA approves Lilly's Kisunla™ for early symptomatic Alzheimer's; pivotal Phase 3 study showed up to 35% cognitive decline reduction over 18 months, 39% lower risk of disease progression
Published:
July 02, 2024
by Eli Lilly & Co.
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Lupin receives tentative U.S. FDA approval for Olopatadine Hydrochloride Ophthalmic Solution, 0.7%; product is a generic equivalent of Pataday® Once Daily Relief, expected annual U.S. sales USD 22 million
Published:
June 27, 2024
by Contify Life Science News
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